MODULE 04 Evaluation of Herbal Drugs B.Pharmacy 6th Semester 2021 (2020-2021) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Evaluation of Herbal Drugs

Objectives

Learning Outcomes

Introduction

WHO Guidelines

Format for Testing Quality of Raw Materials

Standardization of Herbal Drugs

Stability Testing of Herbal Drugs

• Shelf-life
• Challenges
• Mechanism Involved in Changed Product
• Importance
• Stress Testing
• Selection of Batches
• Predictable Changes in Herbal Medicine Product
• Hydrolysis
• Oxidation
• Racemization
• Geometric Isomerization
• Polymerization
• Temperature
• Moisture
• Light

Patenting and Regulatory Requirements of Natural Products

• Patent
• Intellectual Property Rights
• Farmers Rights
• Farmers’ rights and intellectual property rights
• Plant Breeders Rights
• Biopiracy
• Bioprospecting
• Traditional Knowledge
• Case Study of Neem
• Case Study of Turmeric

Regulatory Issues in India

• Herbal Drug Regulation in India
• Drugs and Cosmetics Act, 1940
• The Drugs Technical Advisory Board (DTAB)
• The Central Drugs Laboratory (CDL)
• The Drugs Consultative Committee (DCC)
• Manufacture for sale of Ayurvedic, Siddha and Unani drugs
• The Ayurvedic, Siddha and Unani Drugs Consultative Committee (ASU) 
• Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani Drugs
• Schedule Z (Proposed)